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The investigators' long-term goal is to develop tailored interventions to influence self-management behaviors in young adults with elevated blood pressure (BP). The investigators seek to test an intervention, mobile health (mHealth) to Optimize BP Improvement (MOBILE), that takes advantage of existing applications and our prior work to allow participants to (1) perform self-measured BP monitoring; (2) receive feedback from a cloud-based cardiovascular disease (CVD) detection platform; and (3) receive tailored text messages that encourage engagement in BP reduction behavior. mHealth technology provides an ideal way to deliver healthcare interventions to young adults. Text messaging is especially appealing to college students, more than 91% of whom use smartphones as their main communication device. For this study, the investigators will recruit 42 college students, ages 18 to 29, with elevated BP to participate in formative developmental project and then a 4-week two-armed trial of MOBILE. The aims of this study are:
Aim 1. To refine the MOBILE intervention during a formative phase involving 8-10 students. Outcomes will include finalized motivation-level-tailored text messages designed to prompt behavior change and a self-administered motivational scale to be employed in the Aim 2 and Exploratory Aim study.
Aim 2. To evaluate the feasibility of implementing the MOBILE intervention in 32 college students with elevated BP. The investigators will operationalize MOBILE feasibility as: (a) acceptability to participants, (b) participation rate, (c) texts delivered and opened, (d) fidelity to daily BP measurement protocol, (e) reported technical problems and challenges, and (f) recruitment and attrition rates.
Exploratory Aim. To examine the preliminary impact of the MOBILE intervention on BP reduction (primary outcome) along with sodium intake and hypertension (HTN) knowledge improvement (secondary outcomes) among 32 college students with elevated BP. Hypothesis: The intervention group will have a significantly greater reduction in BP and sodium intake and greater increase in HTN knowledge from baseline to completion, compared to control group.
The investigators seek to test an intervention, mHealth to Optimize BP Improvement (MOBILE), that takes advantage of existing applications and our prior work to allow participants to (1) perform self-measured BP monitoring; (2) receive feedback from a cloud-based CVD detection platform; and (3) receive tailored text messages that encourage engagement in BP reduction behavior. mHealth technology provides an ideal way to deliver healthcare interventions to young adults.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | Following the educational session, the control group participants' BP, ASA24® Dietary Assessment Tool (ASA24; sodium intake), and pre-test knowledge on HTN will be obtained (using Qualitrics). Four weeks later, the participants were scheduled for a follow-up meeting to collect each participant's BP, ASA24, and post-test knowledge on HTN (using Qualitrics). | |
| MOBILE Intervention Group | Experimental | Intervention participants were required to take daily BP, provide their motivation level, and send them to the research assistant to receive the appropriate text messages. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intervention group was asked to take their BP daily and rate their motivation level and communicate with the research assistant. Their level will trigger the appropriate behavioral change SMS prompt. | Behavioral | The investigators showed participants how to use the Health Mate app, upload Withings BP cuff readings, upload historical data to the cloud, read trend lines in their record, rank their daily motivational level, and answer a brief short message service (SMS) question about whether the participants completed the behavioral change task encouraged by the daily message. A one-page instruction sheet with the research team's contact information was provided. Participants were instructed to take their BP daily, before their first meal and encouraged to avoid prior alcohol and caffeine intake as well as physical activity. The participants were instructed to rate their motivational level as low, moderate, or high via SMS when transmitting their BP value. Their level will trigger the appropriate behavioral change SMS prompt. |
| Measure | Description | Time Frame |
|---|---|---|
| BP Level | BP level (systolic and diastolic BP) was taken using the Withings Wireless BP cuff by the participant in the intervention group. | Average value from 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Sodium Intake | ASA24 dietary intake were measured in all participants and sodium intake was evaluated using this measurement. | Average of Day 1 and Day 28 |
| HTN Knowledge | Assess all participants' knowledge on HTN using the Hypertension Knowledge-Level Scale (HK-LS). 6 sub-dimensions: definition, medical treatment, drug compliance, lifestyle, diet, and complications 22-item; Responses; Score ranges from 0-22; Higher scores reflect greater knowledge of HTN. Reliability: Cronbach's alpha 0.82 & Validity: good content, face, and construct validity, test re-test reliability (0.79), and discriminative validity (0.27->0.40). |
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Inclusion Criteria:
Aim 1 Formative Phase:
Aim 2 Inclusion criteria:
Exclusion Criteria:
Aim 2 Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dieu-My T Tran, PhD, RN | University of Nevada, Las Vegas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Nevada Las Vegas | Las Vegas | Nevada | 89154 | United States |
The pilot study has limited data.
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Participants who had HTN stage II (SBP >140 mm Hg or DBP >90 mm Hg) during screening and enrollment, but did not provide a health care provider note were not assigned to a group.
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| ID | Title | Description |
|---|---|---|
| FG000 | Control | Following the educational session, the control group participants' BP, ASA24® Dietary Assessment Tool (ASA24; sodium intake), and pre-test knowledge on HTN will be obtained (using Qualitrics). Four weeks later, the participants were scheduled for a follow-up meeting to collect each participant's BP, ASA24, and post-test knowledge on HTN (using Qualitrics). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 19, 2021 | Mar 20, 2024 |
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Intervention group vs control group
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No masking was done.
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| Average of Day 1 and Day 28 |
| FG001 |
| MOBILE Intervention Group |
Intervention participants were required to take daily BP, provide their motivation level, and send them to the research assistant to receive the appropriate text messages. Intervention group was asked to take their BP daily and rate their motivation level and communicate with the research assistant. Their level will trigger the appropriate behavioral change SMS prompt.: The investigators showed participants how to use the Health Mate app, upload Withings BP cuff readings, upload historical data to the cloud, read trend lines in their record, rank their daily motivational level, and answer a brief short message service (SMS) question about whether the participants completed the behavioral change task encouraged by the daily message. A one-page instruction sheet with the research team's contact information was provided. Participants were instructed to take their BP daily, before their first meal and encouraged to avoid prior alcohol and caffeine intake as well as physical activity. The participants were instructed to rate their motivational level as low, moderate, or high via SMS when transmitting their BP value. Their level will trigger the appropriate behavioral change SMS prompt. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Control | Following the educational session, the control group participants' BP, ASA24® Dietary Assessment Tool (ASA24; sodium intake), and pre-test knowledge on HTN will be obtained (using Qualitrics). Four weeks later, the participants were scheduled for a follow-up meeting to collect each participant's BP, ASA24, and post-test knowledge on HTN (using Qualitrics). |
| BG001 | MOBILE Intervention Group | Intervention participants were required to take daily BP, provide their motivation level, and send them to the research assistant to receive the appropriate text messages. Intervention group was asked to take their BP daily and rate their motivation level and communicate with the research assistant. Their level will trigger the appropriate behavioral change SMS prompt.: The investigators showed participants how to use the Health Mate app, upload Withings BP cuff readings, upload historical data to the cloud, read trend lines in their record, rank their daily motivational level, and answer a brief short message service (SMS) question about whether the participants completed the behavioral change task encouraged by the daily message. A one-page instruction sheet with the research team's contact information was provided. Participants were instructed to take their BP daily, before their first meal and encouraged to avoid prior alcohol and caffeine intake as well as physical activity. The participants were instructed to rate their motivational level as low, moderate, or high via SMS when transmitting their BP value. Their level will trigger the appropriate behavioral change SMS prompt. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Blood Pressure | Mean | Standard Deviation | mm Hg |
| |||||||||||||||
| Hypertension Knowledge-Level Scale (HK-LS) | Assess all participants' knowledge of hypertension using the Hypertension Knowledge-Level Scale (HK-LS). 6 sub-dimensions: definition, medical treatment, drug compliance, lifestyle, diet, and complications 22-item; Responses; Score ranges from 0-22; Higher scores reflect greater knowledge of HTN. Reliability: Cronbach's alpha 0.82 & Validity: good content, face, and construct validity, test re-test reliability (0.79), and discriminative validity (0.27->0.40). | Mean | Standard Deviation | units on a scale |
| ||||||||||||||
| Daily Sodium Intake | Using the ASA-24 Dietary Assessment Tool to examine daily sodium intake. | Mean | Standard Deviation | mg |
| ||||||||||||||
| Body mass index category | Height and weight were collected to calculate participants' BMI. | Count of Participants | Participants |
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| Education | Count of Participants | Participants |
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| Martial Status | Count of Participants | Participants |
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| Insurance coverage | Count of Participants | Participants |
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| Family History of Heart Disease | Count of Participants | Participants |
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| Daily Caloric Intake | Using the ASA-24 Dietary Assessment tool to evaluate participants' daily caloric intake. | Mean | Standard Deviation | calories |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | BP Level | BP level (systolic and diastolic BP) was taken using the Withings Wireless BP cuff by the participant in the intervention group. | College students between ages 18-29 | Posted | Mean | Standard Deviation | mm Hg | Average value from 28 days |
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| Secondary | Sodium Intake | ASA24 dietary intake were measured in all participants and sodium intake was evaluated using this measurement. | College students between the ages of 18-29. | Posted | Mean | Standard Deviation | mg | Average of Day 1 and Day 28 |
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| Secondary | HTN Knowledge | Assess all participants' knowledge on HTN using the Hypertension Knowledge-Level Scale (HK-LS). 6 sub-dimensions: definition, medical treatment, drug compliance, lifestyle, diet, and complications 22-item; Responses; Score ranges from 0-22; Higher scores reflect greater knowledge of HTN. Reliability: Cronbach's alpha 0.82 & Validity: good content, face, and construct validity, test re-test reliability (0.79), and discriminative validity (0.27->0.40). | Posted | Mean | Standard Deviation | units on a scale | Average of Day 1 and Day 28 |
|
28 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control | Following the educational session, the control group participants' BP, ASA24® Dietary Assessment Tool (ASA24; sodium intake), and pre-test knowledge on HTN will be obtained (using Qualitrics). Four weeks later, the participants were scheduled for a follow-up meeting to collect each participant's BP, ASA24, and post-test knowledge on HTN (using Qualitrics). | 0 | 14 | 0 | 14 | 0 | 14 |
| EG001 | MOBILE Intervention Group | Intervention participants were required to take daily BP, provide their motivation level, and send them to the research assistant to receive the appropriate text messages. Intervention group was asked to take their BP daily and rate their motivation level and communicate with the research assistant. Their level will trigger the appropriate behavioral change SMS prompt.: The investigators showed participants how to use the Health Mate app, upload Withings BP cuff readings, upload historical data to the cloud, read trend lines in their record, rank their daily motivational level, and answer a brief short message service (SMS) question about whether the participants completed the behavioral change task encouraged by the daily message. A one-page instruction sheet with the research team's contact information was provided. Participants were instructed to take their BP daily, before their first meal and encouraged to avoid prior alcohol and caffeine intake as well as physical activity. The participants were instructed to rate their motivational level as low, moderate, or high via SMS when transmitting their BP value. Their level will trigger the appropriate behavioral change SMS prompt. | 0 | 15 | 0 | 15 | 0 | 15 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dieu-My Tran (PI) | University of Nevada, Las Vegas | 17028953371 | dieu-my.tran@unlv.edu |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 19, 2021 | Mar 20, 2024 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 19, 2021 | Mar 20, 2024 | ICF_002.pdf |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Diastolic Blood Pressure |
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| Normal or Healthy Weight |
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| Overweight |
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| Obese |
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| Graduate |
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| Married or living together |
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| Divorced/Separated |
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